Addressing threats to health care's core values, especially those stemming from concentration and abuse of power. Advocating for accountability, integrity, transparency, honesty and ethics in leadership and governance of health care.

Friday, February 16, 2007

More on the Zyprexa Memos

We have posted (most recently here , here, and here) about allegations in a New York Times series that Eli Lilly and Company had used questionable marketing tactics to promote its atypical anti-psychotic drug Zyprexa (olanzapine), and especially that the company had suppressed information suggesting that the drug had more adverse effects than previously reported, and then how the company tried to restrict publication of the internal memos on which these allegations were based.

The case continues to bubble. The LosAngeles Times (and others) reported that a New York judge ordered the original copies of the leaked memos returned, but will not suppress their continuing dissemination and discussion, especially on the internet.

A federal judge in New York gave websites a partial victory by acknowledging today that when documents are published on the Internet they take on a life of their own, an existence that cannot be reversed by a court.

Senior U.S. District Court Judge Jack B. Weinstein issued a mixed decision in the closely watched case involving documents relating to the drug Zyprexa. The case pitted opponents of the drug against its manufacturer, Eli Lilly & Co., and both sides claimed at least part of a victory.

The Brooklyn jurist ordered that the documents be returned to the proper officials and enjoined eight parties from further distributing the documents, which are part of civil liability cases. But Weinstein noted that the wave of modern communication made it all but impossible to extend a traditional legal remedy such as an injunction to the Internet.

'To extend the reach of the injunction further might involve the court in attempting to control a constantly expanding universe of those who might have, or will have, access by reason of the original breach,' Weinstein wrote.

'That such an amplified injunction could be enforced effectively is doubtful. Even if enforcement were possible, on policy grounds the risk of unlimited inhibitions on free speech should be avoided when practicable,' he said.

So in the spirit of promoting free speech on this issue, we continue...

Meanwhile, Reuters reported that US Food and Drug Administration staff scientist and whistle-blower David Graham also worried about the Zyprexa case.

U.S. lawmakers should investigate the Food and Drug Administration's handling of side effects linked to Eli Lilly and Co.'s antipsychotic medication, Zyprexa, an agency whistle-blower said on Tuesday.

FDA scientist Dr. David Graham told a congressional hearing the drugmaker and the agency knew 'for a long time' about the risk of weight gain from Zyprexa that could trigger diabetes.

While such side effects were eventually added to the drug's prescribing instructions, Graham testified it was not clear how the agency handled the information or made the decision to alter the label.

'FDA did its typical dragging its feet on post-marketing safety issues,' he told Reuters after the U.S. House of Representatives Energy and Commerce subcommittee hearing.

Finally, Slate has started reporting about the troubling content of the Zyprexa memos, and may be the first at least quasi main-stream media outlet to actually print one of the memos after the court order.

Today's memo (which comes via furiousseasons.com and appears below and on the following 12 pages) is from a 2001 campaign by Lilly's marketing department to encourage doctors to prescribe Zyprexa. Part pep talk and part "message" script, the memo instructs sales reps to tell primary care physicians to prescribe the anti-psychotic drug directly to their patients rather than refer them to psychiatrists (see page three) because such referrals are often 'expensive' and 'difficult to schedule.' On Page 9, Lilly sales reps are instructed to say that the most common side effect of Zyprexa is … 'somnolence.'

The memo sounds an awful lot as though Lilly wants its sales reps to tell primary-care physicians to prescribe Zyprexa for off-label uses. The law permits doctors to do so, but Lilly's executive vice president of science and technology, has stated flatly: 'We do not engage in off-label promotion.' That's difficult to square with the script on Page 3. 'Doctor, you know your patients better than any other clinician,' the memo reads, before describing three patient types a primary care physician would commonly see in his office: 'Martha,' an aged widow who is difficult for her family to manage at home; 'David,' who suffers from a probable 'mood disorder'; and Christine, a twentysomething who struggles with 'a history of poor work performance.' None of these hypothetical patients would appear to suffer from schizophrenia or bipolar disorder, which are the only two conditions Zyprexa is approved for.

It sounds like the arguments that Eli Lilly really did try to bury discussion of Zyprexa's adverse effects, and try to get physicians to prescribe the drug off label are getting harder and harder to refute.

I would add that as a primary care physician, I have been troubled by the pushes I have perceived to get us to screen for depression even in patients who do not appear depressed, and aggressively prescribe SSRIs and even atypical anti-psychotics on our own for depression, before and often in lieu of psychiatric attention and treatment. I have gotten the impression that some people thought we are not doing our jobs if we are not handing out SSRIs to just about everyone who felt a bit "down," and using even more aggressive medication in people with more severe symptoms. Now I'm beginning to think the pushes I perceived were there, were at least partially coming from pharmaceutical marketing, and were not just a product about our feelings of inadequacy when treating psychiatric disease.

And to conclude, like a broken record, if pharmaceutical companies want to earn back some of their lost trust, they will have to publicly and clearly forgo these sorts of over-aggressive and questionable marketing practices.

For other opinions on the Zyprexa case, see the Clinical Psychology and Psychiatry blog here and PharmaGossip here and here.

1 comment:

Dr. Poses, you state:I would add that as a primary care physician, I have been troubled by the pushes I have perceived to get us to screen for depression even in patients who do not appear depressed, and aggressively prescribe SSRIs and even atypical anti-psychotics on our own for depression, before and often in lieu of psychiatric attention and treatment.

I would ask you, as a PCP, to think back 20 years and try to remember the "arguments" used to have you treat diabetics with rDNA insulin. Did reps tell you rDNA human insulin was "better" than old (dirty) animal insulins? If so, did they actually define BETTER? In all the literature I've seen, rDNA genetically engineered human insulin was "better" for (1)those few patients who had allergic response to animal products, and (2) Lilly's bottom line.

Were you also told that rDNA insulin caused NO allergic responses? WRONG! Scientific literature continues to accumulate showing otherwise.

Were you told that rDNA insulin was "just like the human body makes, and who WOULDN'T want to take HUMAN insulin?" Again, no supporting documents.

Were you advised that animal insulin was going to be withdrawn from the market and soon the ONLY insulin available would be rDNA materials? Since Lilly had the power to actually remove their own animal products from the market, this became a manufactured reality.

The promotion of rDNA insulin was a precursor of marketing techniques that have become the "business model." And when lie after lie becomes exposed, there are several tactics employed by Lilly to mitigate the truth: (1) Blame the patient, blame the disease; (2) Remove competing products; (3) [as dangers are revealed] lessen corporate accountability by adding "additional" warnings to package insert (25 now vs. 8 with animal insulin).

If nothing else, the promotion of rDNA insulin blazed the trail for corporate behavior that has finally come to light with this Zyprexa debacle. But who speaks for all those diabetics who have been harmed or killed by rDNA insulin? No one. And what are the only products remaining for Type 1 insulin-using diabetics? rDNA insulin and newly-patented analogs.

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